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    Summary
    EudraCT Number:2022-003016-87
    Sponsor's Protocol Code Number:C3651003
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-003016-87
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY
    TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF
    PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED
    CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL
    TREATMENT PERIOD
    ESTUDIO DE FASE 2, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO PARA INVESTIGAR LA EFICACIA, LA SEGURIDAD Y LA TOLERABILIDAD DE PONSEGROMAB EN PACIENTES CON CÁNCER, CAQUEXIA Y CONCENTRACIONES ELEVADAS DEL GDF-15, SEGUIDO DE UN PERIODO DE TRATAMIENTO ABIERTO OPCIONAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study of the Efficacy and Safety of Ponsegromab in Patients with
    Cancer, Cachexia and Elevated GDF-15.
    Estudio de fase 2 sobre la eficacia y seguridad de ponsegromab en pacientes con cáncer, caquexia y GDF-15 elevado
    A.4.1Sponsor's protocol code numberC3651003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05546476
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 800 7181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePonsegromab
    D.3.2Product code PF-06946860
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPonsegromab
    D.3.9.2Current sponsor codePF-06946860
    D.3.9.4EV Substance CodeSUB219317
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cachexia, a loss of weight due to the catabolism of muscle and fat tissue. The progressive worsening of cachexia impacts a cancer patient’s quality of life and contributes to poor survival.
    Caquexia, una pérdida de peso causada por el catabolismo del tejido muscular y graso. El empeoramiento progresivo de la caquexia afecta a la calidad de vida de los pacientes con cáncer y contribuye a una peor supervicencia
    E.1.1.1Medical condition in easily understood language
    Cachexia is a loss of appetite with wasting of the body and weakness due to a severe chronic illness such as cancer.
    La caquexia es una pérdida de apetito con deterioro del cuerpo y debilidad debido a una enfermedad crónica grave como el cáncer
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10064015
    E.1.2Term Cancer cachexia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of ponsegromab compared with
    placebo on body weight in participants with cancer, cachexia, and elevated concentrations of GDF-15.
    Evaluar el efecto del ponsegromab en comparación con placebo sobre el peso corporal en participantes con cáncer, caquexia y concentraciones elevadas de GDF-15.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of ponsegromab compared to
    placebo on physical activity and gait as measured by wearable digital sensors in participants with cancer, cachexia, and elevated concentrations of GDF-15.
    - To evaluate the effect of ponsegromab compared to placebo on the appetite-related symptoms as measured by FAACT in participants with cancer, cachexia, and elevated concentrations of GDF-15.
    - To evaluate the effect of ponsegromab compared to placebo on anorexia/appetite nausea, vomiting, and fatigue measured by the CRCSD, Pfizer-developed instrument, in participants with cancer, cachexia, and elevated concentrations of GDF-15.
    - To characterize the safety and tolerability of repeated SC administrations of ponsegromab compared to placebo in participants with cancer, cachexia, and elevated concentrations of GDF-15.
    -Evaluar el efecto de ponsegromab en comparación con el placebo sobre la actividad física y la marcha con las mediciones de sensores digitales portables en participantes con cáncer, caquexia y concentraciones elevadas de GDF15.
    -Evaluar el efecto de ponsegromab en comparación con el placebo sobre los síntomas relacionados con el apetito conforme a las mediciones de FAACT en participantes con cáncer, caquexia y concentraciones elevadas de GDF-15.
    -Evaluar el efecto de ponsegromab en comparación con el placebo sobre la anorexia/apetito, náuseas, vómitos y cansancio, medidos mediante el diario de síntomas de la caquexia relacionados con el cáncer CRCSD, un instrumento desarrollado por Pfizer, en participantes con cáncer, caquexia y concentraciones elevadas de GDF-15.
    -Caracterizar la seguridad y tolerabilidad de administraciones s.c. repetidas de ponsegromab en comparación con placebo en participantes con cáncer, caquexia y concentraciones elevadas de GDF-15.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants aged ≥18 years (or the minimum age of consent if >18 in accordance with local regulations) at Screening who have signed informed consent.
    a. A female participant is eligible to participate if she is not pregnant or
    breastfeeding.
    b. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
    Disease Characteristics:
    2. Documented histologic or cytologic diagnosis of NSCLC, PANC, or CRC receiving standard of care (which may include systemic therapy).
    3. Cachexia defined by Fearon criteria of weight loss as (See Section 8.1.1 for details if the participant’s body weight is unavailable from medical record):
    - BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to
    Screening;
    or
    - involuntary weight loss of >5% within 6 months prior to screening irrespective of BMI.
    4. Serum GDF-15 concentrations of ≥1.5 ng/mL (as measured using the Investigational Use Only Roche Elecsys GDF 15 assay)10 at Screening.
    5. Participants who are assessed by the investigator to be able to participate for Part A with ECOG PS ≤3.
    Other Inclusion Criteria:
    6. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    1. Participantes con ≥ 18 años (o la edad mínima de consentimiento si es > 18 años de acuerdo con la normativa local) en la selección que tengan el consentimiento informado firmado.
    a. Las participantes de sexo femenino serán aptas para participar si no están embarazadas o en periodo de lactancia.
    b. Véase el apéndice 4 del protocolo para ver los criterios reproductivos para los participantes varones (sección 10.4.1) y mujeres (sección 10.4.2).
    Características de la enfermedad:
    2. Diagnóstico histológico o citológico documentado de NSCLC, PANC o CRC que reciba tratamiento estándar (que puede incluir terapia sistémica).
    3. Caquexia definida conforme a los criterios de pérdida de peso de Fearon como (ver los detalles en la sección 8.1.1 del protocolo si el peso corporal del participante no figura en la historia clínica):
    - IMC < 20 kg/m2 con pérdida involuntaria de > 2 % en los 6 meses previos a la selección;
    o bien
    - pérdida involuntaria de > 5 % en los 6 meses previos a la selección independientemente del IMC.
    4. Concentraciones séricas de GDF-15 de ≥ 1,5 ng/ml (medidas mediante el ensayo GDF-15 Roche Elecsys para uso solamente en investigación)10 en la selección.
    5. Participantes que sean evaluados por el investigador para poder participar en la Parte A con un ECOG PS ≤ 3.
    Otros criterios de inclusión:
    6. Participantes que estén dispuestos y puedan cumplir con todas las visitas programadas, el plan de tratamiento, los análisis, las consideraciones de estilo de vida y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    Medical Conditions:
    1. Current active reversible causes of decreased food intake, as determined by the Investigator. These causes may include, but are not limited to:
    - NCI CTCAE Grade 3 or 4 oral mucositis;
    - NCI CTCAE Grade 3 or 4 GI disorders (nausea, vomiting, diarrhea, and constipation);
    - Mechanical obstructions making patient unable to eat.
    2. Receiving tube feedings or parenteral nutrition (either total or partial) at the time of Screening or Randomization.
    3. Cachexia caused by other reasons, as determined by the investigator, including, but not limited to:
    - Severe COPD requiring use of home O2;
    - NYHA class III-IV heart failure;
    - AIDS.
    4. Undergoing major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patient must be well recovered from acute effects of surgery prior to Screening. Patient should not have plans to undergo major surgical procedures during the study.
    5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
    6. History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody (IgG protein) or molecules made of components of monoclonal antibody.
    Prior/Concurrent Therapy:
    7. Initiation of new treatment with systemic glucocorticoids within the 4 weeks prior to the first dose of study intervention through Week 16; stable (ie, no significant change to dosage or frequency of administration in prior 4 weeks) steroid therapy eg, dexamethasone as part of pre-medication or daily oral prednisone is permissible. Refer to Section 6.9 and Appendix 10.
    8. Concurrent administration with anamorelin hydrochloride (eg, within 30 days prior to the first dose of study intervention through Week 16). Refer to Section 6.9 and Appendix 10.
    Prior/Concurrent Clinical Study Experience:
    9. Concurrent investigational products (including drug, biologic agents, or vaccines) are not permitted within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) of the first dose of study intervention through the duration of the study (including both Part A and B). Refer to Section 6.9 and Appendix 10.
    10. Enrollment in a previous study with ponsegromab.
    Diagnostic Assessments:
    11. History of severe liver disease or cirrhosis, unrelated to metastatic cancer. Potential study participants with the following liver function test abnormalities will also be excluded:
    - Total bilirubin ≥1.5 × ULN (except for Gilbert’s syndrome)
    - AST >3 × ULN (AST > 5X ULN if there is liver involvement by the tumor)
    - ALT >3 × ULN (ALT >5X ULN if there is liver involvement by the tumor)
    - Alkaline phosphatase >3 x ULN (Alkaline phosphatase >5X ULN in case of bone metastases).
    12. Renal disease requiring dialysis or eGFR<30 mL/min/1.73m2 calculated using 2021 CKD-EPI Equations described in Appendix 7.
    Other Exclusion Criteria:
    13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
    Afecciones médicas:
    1. Causas reversibles activas actuales de disminución de la ingesta de alimentos, según lo determinado por el investigador. Estas causas pueden incluir, entre otras:
    - Mucositis oral de grado 3 o 4 en NCI CTCAE;
    - Trastornos de grado 3 o 4 en NCI CTCAE [náuseas, vómitos, diarrea y estreñimiento];
    - Obstrucciones mecánicas que hacen que el paciente no pueda comer.
    2. Recibir alimentación por sondas o nutrición parenteral (total o parcial) en el momento de la selección o de la aleatorización.
    3. Caquexia causada por otras razones, determinadas por el investigador, que incluyen, entre otras:
    - EPOC grave que requiere el uso de O2 en el hogar;
    - Insuficiencia cardiaca de clase III-IV de la NYHA;
    - Sida.
    4. Someterse a cirugía mayor (la colocación del acceso venoso central y las biopsias tumorales no se consideran cirugía mayor) en las 4 semanas previas a la aleatorización. El paciente debe recuperarse bien de los efectos agudos de la cirugía antes de la selección. El paciente no debe tener planes de someterse a intervenciones quirúrgicas importantes durante el estudio.
    5. Otras enfermedades o trastornos psiquiátricos, incluidas las ideas y conductas de suicidio recientes (durante el último año) o activas, o anomalías de laboratorio que puedan aumentar el riesgo de participar en el estudio o, según la opinión del investigador, causar que el participante resulte inadecuado para el estudio.
    6. Antecedentes de reacción alérgica o anafiláctica a cualquier anticuerpo monoclonal terapéutico o de diagnóstico (proteína IgG) o moléculas fabricadas de componentes de anticuerpos monoclonales.
    Tratamientos anteriores/concurrentes:
    7. Inicio de un nuevo tratamiento con glucocorticoides sistémicos en las 4 semanas previas a la primera dosis del tratamiento del estudio hasta la semana 16. Terapia esteroidea estable (es decir, no se permite ningún cambio significativo en la dosis ni en la frecuencia de administración en 4 semanas anteriores), por ejemplo, dexametasona como parte de la premedicación o prednisona oral diaria. Véase la sección 6.9 y el apéndice 10 del protocolo.
    8. Administración concurrente con hidrocloruro de anamorelina (p. ej., en los 30 días previos a la primera dosis del tratamiento del estudio hasta la semana 16). Véase la sección 6.9 y el apéndice 10 del protocolo.
    Experiencia anterior/concurrente en estudios clínicos:
    9. El uso de productos en fase de investigación (incluidos fármacos, agentes biológicos o vacunas) no está permitido en el plazo de 30 días (o según lo determine el requisito local) o de 5 semividas (el periodo que sea más largo) de la primera dosis del tratamiento del estudio durante todo el estudio (incluidas las Partes A y B) Véase la sección 6.9 y el apéndice 10.
    10. Inscripción en un estudio previo con ponsegromab.
    Evaluaciones de diagnóstico:
    11. Antecedentes de enfermedad grave del hígado o cirrosis, no relacionadas con el cáncer metastásico. Se excluirá a los posibles participantes del estudio con las siguientes anomalías en el análisis de la función hepática:
    - Bilirrubina total ≥ 1,5 × LSN (excepto para el síndrome de Gilbert)
    - AST > 3 × LSN (AST > 5 × LSN si el tumor afecta al hígado)
    - ALT > 3 × LSN (ALT > 5 × LSN si el tumor afecta al hígado)
    - Fosfatasa alcalina > 3 × LSN (fosfatasa alcalina > 5 × LSN en caso de metástasis óseas)
    12. Enfermedad renal que requiere diálisis o eGFR < 30 ml/min/1,73 m2 calculado utilizando las ecuaciones CKD-EPI de 2021 descritas en el apéndice 7 del protocolo.
    Otros criterios de exclusión:
    13. Personal del centro de investigación o empleados de Pfizer directamente involucrados en la realización del estudio, personal del centro supervisado por el investigador y sus respectivos familiares.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline body weight at Week 12.
    Cambio respecto al valor de referencia del peso corporal en la semana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    semana 12
    E.5.2Secondary end point(s)
    Change from baseline in physical activity and gait endpoints measured with remote digital sensors at Week 12.
    - Moderate to vigorous physical activity time;
    - Sedentary activity time;
    - Non sedentary activity time;
    - Total vector magnitude;
    - Mean activity level during M6min;
    - Mean gait speed;
    - 95th percentile gait speed.
    Change from baseline in FAACT sub-scale scores at Week 12:
    - FAACT-ACS;
    - FAACT-5IASS.
    Change from baseline score for the questions from the CRCSD at Week 12 related to:
    - Anorexia/appetite;
    - Nausea and vomiting;
    - Fatigue.
    Incidence of adverse events, safety laboratory tests, vital signs and ECG abnormalities
    Cambio con respecto al valor de referencia en criterios de valoración de la actividad física y la marcha medidos con sensores digitales remotos en la semana 12:
    - Tiempo de actividad física entre moderada y vigorosa
    - Tiempo de actividad sedentaria
    - Tiempo de actividad no sedentaria
    - Magnitud total de vectores
    - Nivel medio de actividad durante M6 min
    - Velocidad media de marcha
    - Velocidad de marcha del percentil 95
    Cambio respecto al valor de referencia en las puntuaciones de la subescala de FAACT en la semana 12:
    - FAACT-ACS;
    - FAACT-5IASS
    Cambio respecto a la puntuación de referencia en las preguntas del diario de síntomas de la caquexia relacionados con el cáncer CRCSD en la semana 12 relacionadas con:
    - Anorexia/apetito
    - Náusea y vómitos
    - Cansancio
    Incidencia de acontecimientos adversos, pruebas de laboratorio de seguridad, constantes vitales y anomalías en los ECG
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12
    thorough the study for secondary endpoint
    semana 12
    a lo largo del estudio para el criterio de valoración secundario
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    China
    Japan
    Taiwan
    United States
    France
    Poland
    Bulgaria
    Spain
    Czechia
    Hungary
    Slovakia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    último paciente- última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 67
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 101
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 168
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The study design includes an optional open-label treatment period for up to 1 year. An expanded access program may be available after the open label treatment period.
    El diseño del estudio incluye la oportunidad de ingresar en un período de tratamiento abierto opcional durante un máximo de 1 año. Puede estar disponible un programa de acceso ampliado tras el periodo de tratamiento abierto
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-17
    P. End of Trial
    P.End of Trial StatusOngoing
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